Z-2033-2017 Class II Terminated
FDA device recall Z-2033-2017 was initiated by Terumo Medical Corporation on November 6, 2015 and is designated Class II. Reason for recall: Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no … The recall status is terminated (terminated May 12, 2017). Affected quantity: 5,252 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2017
- Initiation Date
- November 6, 2015
- Termination Date
- May 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,252 eaches
Product Description
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Reason for Recall
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Distribution Pattern
Nationwide Distribution.
Code Information
Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03